FDA Approves ABRAXANE(R) for Pancreatic Cancer, Could Nuvilex's Treatment Be Next

NEW YORK, NY--(Marketwired - Sep 9, 2013) - After presenting the results of its large scale Phase III clinical trial at the 2013 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology in late January, the U.S. Food and Drug Administration (FDA) moved quickly to approve Celgene Corp.'s ABRAXANE® when used in combination with gemcitabine. Celgene announced late last Friday that the FDA has approved its supplemental new drug application of the combination as first-line treatment for late-stage, metastatic pancreatic cancer.

The approval of the combination for first-line use means that it is now the treatment of choice for the disease. Oddly, this news may account for the late day rally last Friday in Nuvilex, Inc.'s (OTCQB: NVLX) shares as they very well could be next in line to approach the FDA with even better data than Celgene. Because pancreatic cancer is difficult to diagnose and treat until it is at an advanced stage, it's clear to see why the FDA moves quickly on any drug or treatment that proves it can extend lives of those with this devastating disease.

The FDA approval of the ABRAXANE-gemcitabine combination is the first new treatment to be approved for adenocarcinoma of the pancreas in nearly eight years and now replaces the gemcitabine-TARCEVA (erlotinib) combination, which was approved in 2005, as first-line therapy. Prior to that latter approval, single-agent gemcitabine, also known as GEMZAR®, had been the treatment of choice (the "gold standard") for the disease since its approval by the FDA in 1996.

What should get shareholders of Nuvilex excited about the company's future is the actual data the FDA used to quickly approve the ABRAXANE-gemcitabine combination for pancreatic cancer.

ABRAXANE is a form of the chemotherapy drug paclitaxel (TAXOL®) that has been modified by the addition of a human protein called albumin. The combination of ABRAXANE with gemcitabine, improved overall survival in patients with metastatic pancreatic cancer by nearly two months (8.5 months vs. 6.7 months) when compared with gemcitabine alone during the phase III clinical trial. Also, Celgene's results showed that the ABRAXANE-gemcitabine combination gave a 59% increase in one-year survival rate over that seen with gemcitabine alone.

By comparison, two independent Phase II clinical trials revealed that Nuvilex's pancreatic cancer treatment, namely the combination of tiny capsules containing live drug-activating cells together with the single cancer drug ifosfamide (used for many years to treat a variety of cancers), helped patients to a far better outcome than that previously reported with standard single-drug gemcitabine and even that reported for the just approved ABRAXANE-gemcitabine combination.

Those results included an increase of about 4 months in median survival time over gemcitabine alone versus the 1.8 months seen with the ABRAXANE-gemcitabine combination. The results included a 100% increase in the one-year survival rate as compared to gemcitabine versus a 59% increase for the ABRAXANE-gemcitabine combination. The results obtained with Nuvilex's treatment are even more noteworthy given that only one-third of the dose of ifosfamide normally used to treat other types of cancer was used in the Phase II trials for advanced, inoperable pancreatic cancer.

Another apparent advantage for Nuvilex's treatment compared to the ABRAXANE-gemcitabine combination concerns the side effects (toxicities) associated with both treatments. Significant and severe drug-associated toxicities were seen with the ABRAXANE-gemcitabine combination, whereas with Nuvilex's treatment, side effects were essentially non-existent. The lack of side effects from live-cell encapsulation-ifosfamide combination is undoubtedly related to the low dose of ifosfamide used.

Nuvilex is currently preparing for future Phase III clinical trials with the hopes of also gaining FDA approval of their unique live-cell encapsulation-based treatment for advanced, inoperable pancreatic cancer.

The American Cancer Society estimates that in the U.S. alone, 45,220 new cases of pancreatic cancer will be diagnosed in 2013 and 38,460 deaths will be attributable to the dreaded disease this year.

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